Low-Risk, Early Stage Breast CancerNCT07629206
Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
A study testing Cryoablation in people with Low-Risk, Early Stage Breast Cancer, run by IceCure Medical Ltd. at 3 sites in United States.
Trial summary
The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Low-Risk, Early Stage Breast Cancer
- What is being tested?
- Cryoablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jul 2026to Sep 2034
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Provision of a signed and dated informed consent form.
- Age ≥70
- Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria:
- Unifocal primary disease
- Tumor size ≤1.5 cm in greatest diameter
- Estrogen receptor positive, Progesterone receptor positive, and HER2 negative
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- Low-risk tumor biology, defined as Ki67<15% or confirmed by genomic testing. In cases where Ki67 is ≥15%, low-risk status must be confirmed by genomic testing, which will prevail.
- Lesions must be sonographically visible at the time of treatment
- Clinically negative lymph node (N0).
Who cannot join
- Presence of lobular carcinoma.
- Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%.
- Evidence of lymphovascular invasion.
- Presence of multifocal and/or multicentric breast cancer.
- Presence of multifocal suspicious calcifications.
- Presence of inflammatory features.
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- Previous ipsilateral breast radiation
- Neoadjuvant endocrine treatment is provided to reduce the tumor size.
- Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies.
- Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
- Allergy to local anesthesia.
- Any other reason defined as inoperable declared by a physician.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The West Clinic, PC dba West Cancer Center
Germantown, Tennessee, 38138
Lucy Lasher, 901-683-0055, IRBApprovals@westclinic.com
Richard Gilmore, Doctor, MD
- Recruiting
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Glendale, California, 91206
Lily Villalobos, 818-539-9185, villall3@ah.org
Dennis Holmes, Doctor, MD
- Recruiting
Legacy Medical Group-Surgical Oncology at Good Samaritan
Portland, Oregon, 97227
Lauren Study Coordinator, 503-413-8199, lelliott@lhs.org
Nathalie Johnson
About this study
Official title: Post Marketing Data Collection on Use of ProSense® Cryoablation System With Adjuvant Endocrine Therapy for the Treatment of Patients With Low-Risk, Early-Stage Breast Cancer (ChoICE Trial)
The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy.
This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care. Specifically, the study will evaluate recurrence rates following the procedure for up to 5 years post-treatment.
In addition, linkage to claims data will be used to assess long-term outcomes, including breast cancer-related surgeries, mammograms and other breast imaging procedures, breast biopsies, and all-cause mortality.
- Conditions
- Low-Risk, Early Stage Breast Cancer
- Being tested
- Cryoablation
- Keywords
- Cancer, Breast Cancer, Cryoabalation
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Cryoablation procedure, without resection, using the IceCure Medical ProSense® Cryoablation System. Patients will be also provided with adjuvant endocrine therapy for 5 years post-treatment.
The IceCure ProSense® cryoablation system is intended for cryogenic destruction of tissue by the application of extreme cold temperatures.
| Study group | Role | What they receive |
|---|---|---|
| Low-risk, Early satge breast cancer | Experimental | FDA-Approved cryoablation procedure for the indicated population Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate
The percentage of patients who develop confirmed Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
Measured: 5 Years
Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate
The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
Measured: 5 Years
Secondary outcomes (16)
Complete Primary Tumor Ablation Rate
The percentage of patients with complete tumor ablation, defined by adequate iceball coverage of the target tumor during the cryoablation procedure and absence of residual tumor at the 6-month follow-up.
Measured: 6 Months
Procedure duration (minutes)
Procedure duration, defined as the time from procedure initiation to procedure completion, measured in minutes
Measured: The day of the procedure
Number of hospitalization days following the procedure
Length of post-procedural hospitalization (If needed), measured as the number of days from the procedure until hospital discharge.
Measured: 6 Months
Days to resume normal activity
Number of days after cryoablation until return to routine daily activities, as reported by the patient.
Measured: 6 Months
Number of procedure-related outpatient visits
Number of procedure-related outpatient visits post the procedure, which are unplanned in the study schedule of activities
Measured: 6 Months
Physician's satisfaction with the breast's cosmetic results
Assessed using the Sneeuw Questionnaire, an observer-rated assessment of cosmetic changes following treatment. Items are scored on a 4-point scale ranging from 1 (None) to 4 (Severe), with the overall cosmetic result rated from 1 (Poor) to 4 (Excellent).
Measured: 6 Months
Non-serious adverse events (related/non-related to device and procedure) and procedure-related complications.
Number, nature, and percentage of patients with non-serious adverse events (related/nonrelated to device and procedure) and procedure-related complications up to 6 months.
Measured: 6 Months
Local recurrence and Second primary breast cancer rates
The percentage of patients with local breast cancer recurrence or second primary breast cancer.
Measured: 5 Years
Patient's satisfaction with cosmetic outcomes
Patients' satisfaction will be assessed at 6-month follow-up and subsequent visits through 5 years using the 'Satisfaction with Breasts' scale from the BREAST-Q 2.0 Patient-Reported Outcome (PRO) Breast-Conserving Surgery module. Scores are reported on a 0 (Worst) to 100 (Best) scale.
Measured: 5 Years
Patients' Quality of life (QoL)
Improvement or maintenance of patient's quality of life will be evaluated at 6-month follow-up and subsequent visits through 5 years, compared to baseline, using two scales from the BREAST-Q 2.0 PRO Breast-Conserving Surgery module: Physical Well-Being: Chest, and Psychosocial Well-Being. BREAST-Q has domain scores reported on a 0 (Worst) to 100 (Best) scale.
Measured: 5 Years
Locoregional recurrence (LRR) rate
The percentage of patients who develop locoregional recurrence within 5 years post-procedure.
Measured: 5 Years
Disease-Free Survival (DFS) rate
The percentage of patients without evidence of IBTR, regional, or distant breast cancer recurrence, contralateral breast cancer, or death due to breast cancer.
Measured: 5 Years
Overall Survival (OS) rate
The percentage of participants who did not experience death due to any cause up to 5 years.
Measured: 5 Years
Breast cancer survival rate
The percentage of patients who did not experience death due to breast cancer up to 5 years.
Measured: 5 Years
Rate of discontinuation of routine follow-up procedures
The percentage of patients who discontinue routine breast-related follow-up procedures.
Measured: 5 Years
Serious adverse events (related/non-related to device and procedure).
The number, nature, and percentage of patients experiencing serious adverse events (SAEs), related and non-related to the device and procedure.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start17 Jul 2026
- Primary completionJul 2034 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low-Risk, Early Stage Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IceCure Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629206
- Sponsor's protocol ID
- ICM-BC-003
- Status last verified
- Oct 2026
- First submitted
- 12 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fine RE, Gilmore RC, Tomkovich KR, Dietz JR, Berry MP, Hernandez LE, Columbus KS, Seedman SA, Fisher CS, Han LK, Manahan ER, Hicks RD, Vaidya RP, Curcio LD, Sevrukov AB, Kenler AS, Taback B, Chen M, Miller ME, Gold L, Anglin BV, Aoun HD, Simmons RM, Feldman SM, Boolbol SK. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol. 2024 Oct;31(11):7273-7283. doi: 10.1245/s10434-024-16181-0. Epub 2024 Sep 16.
PubMed 39283572